To Evaluate the Safety and Tolerability, Pharmacokinetics... | NCT03745001

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single dose study part	Experimental	there will be 7 cohorts of healthy volunteers dosed with single doses of EHP-101 (7 planned dose levels) or with placebo and 1 potential additional cohort (also dosed with single dose of EHP-101 or placebo)	Drug: EHP-101 Liquid single dose Drug: Matching placebo
Multiple dose study part	Experimental	there will be 3 cohorts of healthy volunteers dosed with multiple doses of EHP-101 (3 planned dose levels) or placebo and 1 potential additional cohort (also dosed with multiple doses of EHP-101 or placebo)	Drug: EHP-101 Liquid multiple doses Drug: Matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EHP-101 Liquid single dose	Drug	One single oral administration with EHP-101 liquid formulation. The doses will be ascending per cohort from 0.91 mg to 200 mg. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) following single and multiple ascending oral doses for 30 days after dosing.	This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.	From the time of the first dose and continued until 30 days after

Secondary Outcomes

Measure	Description	Time Frame
Time to reach VCE-004.8 maximum concentration after a single drug administration (Tmax).	Serum samples will be collected on Day 1: 1 hour predose; 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 6 hours; 9 hours; 12 hours; 14 hours; 15 hours; 16 hours post dose, on Day 2: 24 hours post dose, on Day 3: 48 hours post dose, on Day 4: 72 hours post dose, on Day 5: 96 hours postdose, on Day 6: 120 hours postdose, on Day 7: 144 hours post dose, on Day 8, 168 hours, on Day 9: 192 hours post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above. * samples to be collected on Day 1 only for the modified dose regimen. In one cohort the outcome measure is done once without food intake and once after the intake of a high fat breakfast (in 2 different periods). Both outcomes (with and without breakfast intake) will be compared to assess the effect of a high fast breakfast on VCE-004.8 Tmax.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female subjects ≥ 18 to ≤ 65 years of age.
Body mass index (BMI) range 18 to 34 kg/m².
Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG), echocardiography, ophthalmologic examinations and tests, and laboratory evaluations at screening and admission, as judged by the Investigator.
Cardiac Troponin I level below the upper limit of normal, as defined by the manufacturer.
Ability to understand and the willingness to provide informed consent for participation in the study.
Ability and willingness, as judged by the Investigator, to comply with all study requirements.

Exclusion Criteria:

Any known, documented, or suspected history of:
1. schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a first-degree relative.
2. alcohol or substance abuse within the last 2 years before screening or positive test result(s) for alcohol and or drugs of abuse.
3. Regular alcohol consumption >21 units per week
Use of nicotine or nicotine-containing products during participation in the study.
Caffeine consumption is limited to no more than 2 units per day.
Any known, documented, or suspected hypersensitivity to cannabinoids or any of the excipients of EHP-101 Liquid.
Use of cannabis or cannabinoid-based medications.
Abnormal screening 12-lead ECG interpreted by the Investigator to be clinically significant.
Presence of ophthalmologic abnormalities at baseline, specifically known closed angles, previous laser iridotomy, or severe hypermetropic diagnosis.
Male subjects who are not surgically sterilized and who do not agree to use condoms in combination with partner use of a highly effective method of contraception. Female subjects of childbearing potential who are not using a highly effective method of contraception, as judged by the Investigator, and who do not consent: i) to use a combined barrier method of contraception and ii) to remain on a highly effective method of contraception while receiving study intervention during the study and for at least 90 days after the end of study treatment.
Female subjects who are pregnant, lactating, or planning pregnancy during the course of the study and for 12 weeks thereafter.
Male subjects unwilling to abstain from sperm donation during the study and for 12 weeks thereafter.
Any evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV types 1 and 2) infection.
Subjects who have received an IP within the 12 weeks before the screening visit.
Blood donation or loss (eg, ≥ 400 mL) within 3 months before enrollment and unwilling to abstain from blood donation during the study.
Significant disease or disorder, which, in the opinion of the Investigator or other staff who is directly involved in the study, may either put the subject at risk because of participation in the study or interfere with the subject's ability to participate in the study.
Intake of any metabolic enzyme-affecting drugs from 30 days prior to Day -1 (ie, Check-in).
Vaccination within 30 days prior to enrollment.